FDA.reportPublic FDA data

sotatercept-csrk 45 MG, 2 Vial Kit

RxCUI
2678948
RxNorm name
sotatercept-csrk 45 MG, 2 Vial Kit
Display name
sotatercept-csrk 45 MG, 2 Vial Kit
Full name
sotatercept-csrk 45 MG, 2 Vial Kit
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:38:50

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761363Winrevairsotatercept-csrk351(a)Rx2026-06-01

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
21693ee2-cd23-4137-ac67-066bb3a4a9b7sotatercept-csrk 45 MG, 2 Vial KitSY8These highlights do not include all the information needed to use WINREVAIR safely and effectively. See full prescribing information for WINREVAIR. WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use Initial U.S. Approval: 202420251208
21693ee2-cd23-4137-ac67-066bb3a4a9b7sotatercept-csrk 45 MG, 2 Vial KitPSN8These highlights do not include all the information needed to use WINREVAIR safely and effectively. See full prescribing information for WINREVAIR. WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use Initial U.S. Approval: 202420251208
21693ee2-cd23-4137-ac67-066bb3a4a9b7{2 (sotatercept-csrk 45 MG Injection) } PackGPCK8These highlights do not include all the information needed to use WINREVAIR safely and effectively. See full prescribing information for WINREVAIR. WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use Initial U.S. Approval: 202420251208